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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03495349
Other study ID # 69HCL17_0850
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 5, 2018
Est. completion date January 10, 2021

Study information

Verified date June 2021
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Diabetes is a frequent and serious disease, with many complications. Diabetic foot ulcers are a frequent complication. Infection of diabetic foot ulcers is common, and requires heavy medical and/or surgical treatments. Antibiotherapy is one of the main options for the treatment of the diabetic foot ulcers, but it has many side effects. The aim of this study is to evaluate effectiveness and safety of medical treatments, in this population of patients.


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date January 10, 2021
Est. primary completion date January 10, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adults men and women - Followed for diabetic foot infection (grades 2 to 4 of IWGDF classification) - That accepted to take part in the study Exclusion Criteria: - Legal safeguard - Pregnant women - Patient that can't accept to take part in the study because can't be informed - Exclusive surgical treatment

Study Design


Intervention

Other:
safety and effectiveness of the usual treatments of diabetic foot infections
clinical and biological follow-up necessary to assess the safety and effectiveness of the medical treatments, MOS-SF survey (36-Item Short Form Survey) to study the quality of life.

Locations

Country Name City State
France Groupement Hospitalier Est Bron
France Centre Hospitalier Lyon Sud Pierre-Bénite

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effectiveness of adverse effects in patients treated by antibiotherapy for diabetic foot infection, assessed by clinical or biological methods Effectiveness :
For soft tissue infections, remission is defined by the disappearance of any functional or physical sign of infection,
For osteomyelitis, remission is defined as the absence of clinical and /or radiological recurrence at the initial site one year after antibiotic therapy cessation.
1 year
Primary Occurrence of adverse effects in patients treated by antibiotherapy for diabetic foot infection, assessed by clinical or biological methods Occurrence of side effects:
All clinical and/or biological adverse events will be reported. The severity of any adverse events will be graded according to the criteria of Common Terminology Criteria for Adverse Events (CTCAE) from grade 1 (mild) to 5 (death).
Clinical adverse events included gastrointestinal disorders, skin eruption, pain, weight gain or loss Biological adverse events included impair kidney function, increase liver serum markers, anemia, low neutrophils count, thrombopenia.
1 year
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